RILONACEPT REGENERON Powder and solvent for solution for injection (2012)
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Περιεχόμενα
Name of the medicinal product
Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection.
Qualitative and quantitative composition
Each vial of powder contains 220 mg of rilonacept. After reconstitution, each ml of solution contains 80 mg rilonacept. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder and solvent for solution for injection. The powder is white to off-white. The solvent is a clear colourless solution.
Therapeutic indications
Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome ...
Posology and method of administration
Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS. After proper training in the correct injection technique, patients may self-inject ...
Contraindications
Hypersensitivity to rilonacept or to any of the excipients. Active, severe infections (see section 4.4).
Special warnings and precautions for use
Serious infections Interleukin-1 (IL-1) blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported uncommonly in patients taking Rilonacept Regeneron. ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The concomitant administration of Rilonacept Regeneron with any TNF inhibitor is not recommended (see section 4.4), because an increased incidence of serious ...
Pregnancy and lactation
Pregnancy There are no adequate data from use of rilonacept in pregnant women. Reproductive toxicity studies have been conducted in animals and have shown no effects on fertility or foetal morphology; ...
Effects on ability to drive and use machines
The ability to drive and operate machines may be impaired by some symptoms associated with CAPS. Patients who experience vertigo during Rilonacept Regeneron treatment should wait for this to resolve completely ...
Undesirable effects
The majority of the related adverse events in the clinical trials were classified as injection site reactions, experienced by approximately 50% of the patients in the Phase 3 study. Reported ISRs were ...
Overdose
No case of overdose has been reported. The maximum amount of product that can be safely administered has not been determined. Intravenous administration of Rilonacept Regeneron at doses of up to 2000 mg ...
Pharmacodynamic properties
Pharmacotherapeutic group: Interleukin inhibitors ATC code: L04AC04 This medicinal product has been authorised under Exceptional Circumstances. This means that due to the rarity of the disease it has not ...
Pharmacokinetic properties
Bioavailability of rilonacept after a subcutaneous injection is estimated to be approximately 50%. The average trough levels of rilonacept were approximately 24 µg/ml at steady state following weekly subcutaneous ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated-dose toxicity. Animal studies were conducted to assess reproductive toxicity. In ...
List of excipients
Powder: Glycine Arginine hydrochloride Histidine Histidine hydrochloride monohydrate Polyethylene glycol 3350 Sucrose Solvent: Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life Vial: 2 years. Diluted solution: From a microbiological safety point of view, the product should be used as soon as possible but within 3 hours of reconstitution, because it does not contain ...
Special precautions for storage
Store in a refrigerator. Do not freeze. Keep the vials in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Powder vial: 20 ml clear type I glass vial with rubber stopper and lacquered flip-off aluminium seal containing 220 mg rilonacept. Solvent vial: LDPE vials containing 5 ml water for injections Each pack ...
Special precautions for disposal and other handling
Instructions for reconstitution Using aseptic technique, Rilonacept Regeneron powder should be reconstituted with 2.3 ml of solvent (water for injections) prior to administration. The 2.3 ml of solvent ...
Marketing authorization holder
Regeneron UK Limited, 40 Bank Street, E14 5DS, London, United Kingdom
Marketing authorization number(s)
EU/1/09/582/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 October 2009
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